NCT04761991

Brief Summary

CONCORD is a prospective observational study evaluating the diagnostic accuracy of cardiovascular magnetic resonance (CMR) and computed tomography with fractional flow reserve (CT-FFR) in patients with suspected coronary artery disease, using invasive fractional flow reserve (FFR) as the reference standard.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 17, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

5.1 years

First QC Date

December 17, 2020

Last Update Submit

June 26, 2025

Conditions

Coronary Artery Disease

Keywords

MRICT-FFRcoronary artery disease

Outcome Measures

Primary Outcomes (1)

  • 1. Diagnostic performance of CMR and CT-FFR

    Diagnostic accuracy of CMR perfusion imaging (quantitative and qualitative analysis) and CT-FFR to determine the presence/absence of significant coronary artery disease at the subject level when compared with invasive FFR.

    6 weeks

Secondary Outcomes (10)

  • 1. Diagnostic performance of CMR and CT-FFR

    6 weeks

  • 2. Diagnostic performance of CMR and CT-FFR

    6 weeks

  • 3. Diagnostic performance of CMR T1 mapping

    6 weeks

  • 4. Diagnostic performance of hybrid imaging

    6 weeks

  • Diagnostic performance of strain assessment

    6 weeks

  • +5 more secondary outcomes

Interventions

CMR and CTCA with CT-FFRDIAGNOSTIC_TEST

multi-parametric CMR assessment and CT coronary angiography with FFR assessment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with suspected coronary artery disease referred for invasive coronary angiography

You may qualify if:

  • Patients aged ≥18 years
  • Referred for invasive coronary angiography for investigation of chest pain

You may not qualify if:

  • Recent acute coronary syndrome (\< 6 months)
  • Previous coronary artery bypass grafting
  • Severe claustrophobia
  • Absolute contraindications to CMR - those with MR conditional or safe devices will be included
  • Second-/third-degree atrioventricular block
  • Severe chronic obstructive pulmonary disease
  • Moderate-severe asthma
  • Estimated glomerular filtration rate \<30 ml/min/1.73m2
  • Women who are pregnant, breast-feeding or of child-bearing potential( premenopausal women)
  • Contraindication to iodinated contrast
  • Participation in a research study involving an investigational product in the past 12 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glenfield Hospital

Leicester, Leics, LE3 (QP, United Kingdom

RECRUITING

Related Publications (1)

  • Shergill S, Elshibly M, Parke KS, England R, Wormleighton JV, Das I, Gulsin GS, Hothi SS, Heggie R, Wu O, Kellman P, McIntosh A, McConnachie A, Ladwiniec A, McCann GP, Arnold JR. Cardiovascular magnetic resonance versus coronary computed tomography angiography with fractional flow reserve for diagnosing obstructive coronary artery disease in higher risk patients: rationale and design of CONCORD-A prospective, single-center diagnostic accuracy study. J Cardiovasc Magn Reson. 2025 Aug 14;28(1):101939. doi: 10.1016/j.jocmr.2025.101939. Online ahead of print.

    PMID: 40818667DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Jayanth Arnold

CONTACT

0300 303 1573jra14@le.ac.uk

Mo Elshibly

CONTACT

mmme1@le.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2020

First Posted

February 21, 2021

Study Start

November 5, 2020

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

July 1, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)